Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment reports

Data source

Reference
Reference Type:
secondary source
Title:
Reports of the Scientific Committee on Cosmetology
Author:
Commission of the European Communities
Year:
1988
Bibliographic source:
Scientific Committee on Cosmetology (seventh series), European Communities, 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To determine the skin sensitizing potential of the test chemial in guinea pig.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
no data available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Name of test material (as cited in study report): Acid Red 1 [Red 2G]
Molecular formula : C18H15N3O8S2.2Na
Molecular weight : 509.426 g/mol
Smiles notation : c12c(cc(S(=O)(=O)[O])c(c2O)\N=N\c2ccccc2)cc(S(=O)(=O)[O])cc1NC(C)=O.[Na+].[Na+]
InChl : 1S/C18H15N3O8S2.2Na/c110(22)1914913(30(24,25)26)711815(31(27,28)29)17(18(23)16(11)14)2120125324612;;/h29,23H,1H3,(H,19,22)(H,24,25,26)(H,27,28,29);;/q;2*+1/p2/b2120+;;
Substance type: Organic
Physical state: Solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data available

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 ml of a 7.5% solution in saline
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
0.1 ml of a 7.5% solution in saline
Adequacy of challenge:
not specified
No. of animals per dose:
no data available
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
No. of exposures: 2 times 4 intradermal injections
Exposure period: No data
Test groups: No data
Control group: No data
Site: No data
Frequency of applications: 2 times
Duration: No data
Concentrations: 0.1 ml of 7.5% solution in saline

B. CHALLENGE EXPOSURE
No. of exposures: single
Day(s) of challenge: 14 days after second intradermal injection
Exposure period: No data
Test groups: No data
Control group: No data
Site: No data
Concentrations: 3% solution in saline
Evaluation (hr after challenge): No data
Challenge controls:
no data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
no data available

Results and discussion

Positive control results:
no data available

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
7.5% in saline
No. with + reactions:
0
Clinical observations:
No sensitization observed
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

The intradermal induction and challenge did not reveal any signs of sensitisation.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
The test chemical was considered to be non sensitizing after challenge exposure in guinea pig.
Executive summary:

A sensitization test was carried out in guinea pigs to determined the sensitizing potential of the test chemical. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted.

In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs.

Signs of sensitization were not observed. Hence, the test chemical was considered  to be non sensitizing after challenge exposure in guinea pig.